NCT00514904已完成3 期
Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 7
- 主要终点
- Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
研究概览
简要总结
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 2 and 10 years of age at the time of vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- •Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- •Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
- •Previous vaccination with tetanus toxoid within the last month.
- •History of meningococcal disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..
- •History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
结局指标
主要结局
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
时间窗: One month after vaccination (Post-vaccination, study Month 1)
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
时间窗: During the 4-day (Days 0-3) post-vaccination period
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
次要结局
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values(Pre vaccination (Month 0) and post vaccination (Month 1))
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers(Pre vaccination (Month 0) and post vaccination (Month 1))
- Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values(Pre vaccination (Month 0) and post vaccination (Month 1))
- Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations(Pre vaccination (Month 0) and post vaccination (Month 1))
- Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values(Pre vaccination (Month 0) and post vaccination, (Month 1))
- Anti-polysaccharide (Anti-PS) Antibody Concentrations(Pre vaccination (Month 0) and post vaccination (Month 1))
- Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects < 6 Years of Age With Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects Reporting Specific Adverse Events (AEs)(From Day 0 up to 6 months after vaccination)
- Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after vaccination)
- Number of Subjects Reporting Any Unsolicited Symptoms(Up to one month (Day 0-Day 30) after vaccination)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(From Day 0 up to 6 months after vaccination)
研究者
研究点 (7)
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